Chest Congestion And Cough Hbp
FDA Label NDC 51013-406

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Puracap Pharmaceutical Llc for the product Chest Congestion And Cough Hbp (NDC 51013-406). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each softgel), purpose, uses, ask a doctor before use if you have, directions, other information, inactive ingredients, questions or comments, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Softgel)

Dextromethorphan hydrobromide 10 mg

Guaifenesin 200 mg

Purpose

Cough suppressant

Expectorant

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Ask A Doctor Before Use If You Have

  • cough that occurs with excessive phlegm (mucus)
  • persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

Directions

  • do not exceed recommended dose
  • adults and children 12 years and over:

    •            1 or 2 softgels every 4 hours, not more than 12 softgels in 24 hours

    • children under 12 years of age: ask a doctor

Other Information

  • store at room temperature 15-30°C (59-86°F)
  •  avoid excessive heat above 40°C (104°F)

Inactive Ingredients

FD&C Red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution and white ink

Questions Or Comments

Call toll free: 1-855-215-8180

Principal Display Panel

CVS Chest Congestion & Cough HBP 20 SOFTGELS

NDC: 51013-406-08

*Compare to the active ingredients in Coricidin® HBP Chest Congestion & Cough

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